In the field of medical devices, especially medical devices which are to be implanted in the body in surgical and nonsurgical procedures, such as implantable vascular grafts, it is necessary to provide a sterile protective environment for such grafts during shipping and storage prior to use. The use of blister packages which support vascular grafts in such a sterile environment is known in the art. Typical blister packages include blister trays, which are compression molded plastic members having specifically formed cavities or blister depressions formed therein which accommodate the vascular graft. These blister trays may be covered with a blister cover which is removably adhesively secured to the blister tray to enclose the vascular graft in the depression. As such, the interior of the blister package may be maintained in a sterile environment so that the vascular graft may be transported to the surgical site in a sterile condition. In use, the blister cover is peelably removed from the tray, rendering accessible the graft supported therein.
In order to provide enhanced sterility, the blister package itself may be enclosed in a second or outer blister package having a separate removable sealable blister cover positioned thereover. The outer blister package may also maintain a sterile environment interiorly thereof so that the inner blister package itself can be transported in a sterile condition.
For vascular grafts having relatively simple shapes, it is quite easy to form a blister package which accommodates the graft in a protective manner. Vascular grafts are typically elongate, cylindrical tubes which may include one or more branches at one end thereof. It is quite common to form the blister depressions in the blister tray to the precise shape of the particular graft which is to be supported therein. Furthermore, it is desirable to form the shape of the blister depression to mirror the shape and configuration of the graft as it is to be used or implanted. Such a configuration of the blister depression avoids kinking or bending of the graft during shipping and storage. The graft will thus be presented to the surgeon, prior to implantation, in the shape and configuration in which it is to be used. While it is relatively simple to provide blister depressions in a blister tray for grafts having simple configurations such as an elongate tube or a tube having one or more branches lying in a similar plane, such as is in the case of bifurcated grafts, it is more difficult to form a blister depression which will adequately accommodate grafts having more complex shapes.
One such graft is an aortic arch graft 10 shown in FIG. 1. Graft 10 includes an elongate main tube 12 and a plurality of aligned branch tubes 14 extending from the main tube 12 in parallel fashion. In certain situations where the aortic arch graft is designed to be temporarily connected to external devices, such as for example, a heart-lung machine, the graft 10 may include a lateral branch 16 extending from main tube 12 at a location spaced from the aligned branches 14.
Blister packages of the prior art have not been able to adequately accommodate such a complex-shaped aortic arch graft without sacrificing some degree of protection to the graft during shipment and long term storage.
It is therefore desirable to provide a blister package which is designed to accommodate a complex graft shape such as an aortic arch graft which protects the graft and maintains the graft in a sterile environment.